US-based clinical-stage biotechnology firm Advaxis has begun enrolment and dosing in its Phase III clinical trial (AIM2CERV) of axalimogene filolisbac for the treatment of patients with advanced stage cervical cancer.
Axalimogene filolisbac is an immunotherapy product developed using a live attenuated Listeria monocytogenes (Lm), which is bioengineered to produce an HPV-16 E7 protein fused with a truncated fragment of listeriolysin O (tLLO).
The drug is designed to target the HPV transformed cells for triggering anti-tumour T-cell immunity and destroying immune tolerance in the tumour microenvironment.
The global, randomised Phase III trial will evaluate axalimogene filolisbac as an adjuvant therapy in patients with high-risk, locally advanced carcinoma of the cervix (HRLACC), after primary treatment with chemotherapy and radiation.
The trial will assess the primary objective of disease-free survival (DFS) along with secondary objectives such as overall survival, safety and tolerability.
The trial is to be conducted in collaboration with the GOG Foundation under a Special Protocol Assessment (SPA) agreement with the FDA and will enrol up to 450 patients at 150 global sites.
Last year, the firm reported positive results from the Phase II GOG-0265 trial with better rate of survival in persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC).
The FDA has granted orphan drug designation and fast track designation for axalimogene filolisbac adjuvant therapy in HRLACC and orphan drug designation for stage II-IV cervical cancer.
The drug was further categorised by the European Medicines Agency's (EMA) as an advanced therapy medicinal product (ATMP) for the treatment of cervical cancer.